Elsevier

Ophthalmology

Volume 117, Issue 11, November 2010, Pages 2134-2140
Ophthalmology

Original article
A Treat and Extend Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration: Clinical and Economic Impact

Presented in part at The Association for Research in Vision and Ophthalmology Annual Meeting, Fort Lauderdale, May 2009 and American Academy of Ophthalmology Annual Meeting, San Francisco, CA, October 2009.
https://doi.org/10.1016/j.ophtha.2010.02.032Get rights and content

Purpose

To evaluate the visual outcome, number of injections, and direct medical cost of a “treat and extend” regimen (TER) in managing neovascular age-related macular degeneration (nAMD) with intravitreal ranibizumab.

Design

Retrospective, interventional, consecutive case series.

Participants

Ninety-two eyes of 92 patients met the entry criteria from May 2006 to May 2008.

Methods

All patients with treatment-naïve nAMD were treated monthly until no intraretinal or subretinal fluid was observed on optical coherence tomography (OCT). The treatment intervals were then sequentially lengthened by 2 weeks until signs of exudation recurred. The interval was individualized for each patient in an attempt to maintain an exudation-free macula.

Main Outcome Measures

Change from baseline visual acuity, proportion of eyes losing <3 lines and gaining ≥3 lines at 1 year of follow-up, annual mean number of injections, change from baseline OCT central retinal thickness (CRT), maximum period of extension, and adverse ocular and systemic events.

Results

The mean follow-up was 1.52 years. Mean Snellen visual acuity improved from 20/135 at baseline to 20/77 at 1 year follow-up (P<0.001) and 20/83 at 2 years follow-up (P = 0.002). The proportion of eyes that lost <3 Snellen visual acuity lines at final follow-up was 96% and the proportion that gained ≥3 Snellen visual acuity lines was 32%. The mean OCT CRT decreased from 303 μm at baseline to 238 μm at 1 year follow-up (P<0.001). The mean number of injections over the first year and between years 1 and 2 was 8.36 and 7.45, respectively. The mean maximum period of extension was 79.9 days. No adverse ocular or systemic events were reported during the follow-up period. The direct annual medical cost per patient was $16 114.52 for the TER. The direct annual medical cost per patient ranged from $15 880.07 to $28 314.16 based on previous clinical trial protocols.

Conclusions

Eyes with nAMD experienced significant visual improvement when managed with intravitreal ranibizumab using a TER. This treatment approach also was associated with significantly fewer patient visits, injections, and direct annual medical cost compared with monthly injections such as in the phase III clinical trials.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found after the references.

Section snippets

Methods

Institutional review board approval at Wills Eye Institute was obtained to review patient data for this retrospective, interventional, consecutive case series from 2 treating physicians (CDR and RSK) in a single clinical practice. Informed consent was not required for this deidentified review.

Baseline Characteristics

Ninety-two eyes from 92 patients met the inclusion and exclusion criteria. The mean age was 80.6 years (range, 61–94; standard deviation, 6.6), 61 were female (66.3%), and all participants were Caucasian. There were 48 right eyes (52%) and 50 pseudophakic eyes (54%). These baseline characteristics were comparable to the MARINA, ANCHOR, and PrONTO trials (Table 2). The mean duration of visual symptoms before treatment was 74.8 days (median, 30; range, 1–365). Forty-six eyes (50%) were treated

Discussion

The TER used in this study demonstrated favorable visual acuity results in patients with nAMD with significantly fewer visits and intravitreal injections compared with treatment in a fixed, monthly fashion such as in the MARINA and ANCHOR trials. Compared with the PrONTO study, there were a lower mean number of office visits and tests with a higher total annual mean number of treatments. The direct medical costs between the PrONTO and TER were similar.

Owing to the patient, physician, and

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Manuscript no. 2009-821.

Financial Disclosure(s): The authors have made the following disclosures:

Carl D. Regillo - consultant - Genentech, Inc., Novartis Pharmaceuticals Corp., and Alcon Laboratories, Inc.

Richard S. Kaiser - consultant and lecturer - Genentech, Inc.

None of the authors received financial support from Genentech, Inc. or other commercial sources for this study.

Supported by the Heed Ophthalmic Foundation (OPG) and the Ronald G. Michels Fellowship Foundation Award (OPG).

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